,Context, Quality Policy and Objectives
The ISO 9001:2015 Standard puts a strong focus on strategic management. What this means is a closer connection in the interrelationships between business policy, objectives and results.
Interpreting ISO 9001:2015, we can relate to 3 key areas of Business Strategy:
If we consider the literal definition of Context, we arrive at the term "circumstance". Therefore, we can consider our Context to be those circumstances that affect our ability to provide a product or service. In order to comprehend those circumstances, we must understand our business. What are our strengths and weaknesses (internal factors) and what opportunities and threats must we consider (external factors)? What requirements must we satisfy and how to we intend to achieve these results?
A common misconception is that ISO 9001:2015 requires quality objectives to be based on the company's quality policy; however, the actual requirement is that they are consistent with this policy. To be effective, quality objectives do not require line-by-line linkage to the quality policy, only align with it's intent. Quality objectives must take into account those strategic issues arising from an analysis of current business performance and opportunities.
Most quality policies cite improvement, customer satisfaction and quality. Many however, fall short on the commitment to satisfy applicable requirements. Meeting customer requirements is one piece of the whole; however, with a heightened focus on internal and external factors, interested parties and their requirements as part of determining the context of the organization, the quality policy needs to take these other requirements into consideration.
Per ISO 9001:2015, there are 4 key components that a Quality Policy must encompass:
The Quality Management System (QMS) must be aligned with the Business Strategy. If the organization has strategic initiatives in place, they must connect with the Quality Policy. There must be linkage between the QMS and the Business. The Quality Policy must reflect the strategic direction of the company.
Can you connect the dots between your organization's strategic direction, quality objectives and quality policy?
Bloom's Taxonomy and Learning Objectives
Employee training and education should be based upon learning objectives which consider both the intended audience, as well as the level of learning that is required. In simple terms, the depth and extent of employee training should consider their job description, assigned work activities and job responsibilities. Some employees may only need to learn information at a knowledge level, where others may be required to achieve learning at higher levels, including comprehension, analysis and evaluation.
The categories below are taken from Bloom's Taxonomy, which is used to classify educational learning objectives into levels of complexity and specificity. The higher the level, the more in-depth, and likely longer, the training program should be.
1. Knowledge- Knowledge is defined as the remembering of previously learned material. This may involve the recall of a wide range of material, from specific facts to complete theories, but all that is required is the bringing to mind of the appropriate information. Knowledge represents the lowest level of learning outcomes in the cognitive domain.
Illustrative General Instructional Objectives: Knows common terms. Knows specific facts. Knows methods and procedures. Knows basic concepts. Knows principles.
Illustrative Verbs for Stating Specific Learning Outcomes: Defines, describes, identifies, labels, lists, matches, names, outlines, reproduces, selects, states.
2. Comprehension- Comprehension is defined as the ability to grasp the meaning of material. This may be shown by translating material from one form to another (words or numbers), by interpreting material (explaining or summarizing, and by estimating future trends (predicting consequences or effects). These learning outcomes go one step beyond simple remembering of material, and represent the lowest level of understanding.
Illustrative General Instructional Objectives: Understands facts and principles. Interprets verbal material. Interprets charts and graphs. Translates verbal material to mathematical formulas. Estimates consequences implied in data. Justifies methods and procedures.
Illustrative Verbs for Stating Specific Learning Outcomes: Converts, defends, distinguishes, estimates, explains, extends, generalizes, gives examples, infers, paraphrases, predicts, rewrites, summarizes.
3. Application- Application refers to the ability to use learned material in new and concrete situations. This may include the application of such things as rules, methods, concepts, principles, laws, and theories. Learning outcomes in this area require a higher level of understanding than those of comprehension.
Illustrative General Instructional Objectives: Applies principles to new situations. Applies theories to practical situations. Solves mathematical problems. Constructs charts and graphs. Demonstrates correct usage of a procedure.
Illustrative Verbs for Stating Specific Learning Outcomes: Changes, computes, demonstrates, discovers, manipulates, modifies, operates, predicts, prepares, produces, relates, shows, solves, uses.
4. Analysis- Analysis refers to the ability to break down material into its component parts so that its organizational structure may be understood. This may include the identification of the parts, analysis of the relationship between parts, and recognition of the organizational principles involved. Learning outcomes here present a higher intellectual level than comprehension and application because they require an understanding of both the content and structural form of the material.
Illustrative General Instructional Objectives: Recognizes unstated assumptions. Recognizes logical fallacies in reasoning. Distinguishes between facts and inferences. Evaluates the relevancy of data. Analyses the organizational structure of a work (art, music, writing).
Illustrative Verbs for Stating Specific Learning Outcomes: Breaks down diagrams, differentiates, discriminates, distinguishes, identifies, illustrates, infers, outlines, points out, relates, selects, separates, subdivides.
5. Synthesis- Synthesis refers to the ability to put parts together to form a new whole. This may involve the production of a unique communication (theme or speech), a plan of operations (research proposal), or a set of abstract relations (scheme for classifying information). Learning outcomes in this area stress creative behaviors, with major emphasis on the formulation of new patterns and structures.
Illustrative General Instructional Objectives: Writes a well-organized theme. Gives a well-organized speech. Writes a creative short story (or poem). Proposes a plan for an experiment. Integrates learning from different areas into a plan for solving a problem. Formulates a new scheme for classifying objects (or events, or ideas).
Illustrative Verbs for Stating Specific Learning Outcomes: Categorizes, combines, complies, composes, creates, devises, designs, explains, generates, modifies, organizes, plans, rearranges, reconstructs, relates, reorganizes, revises, rewrites, summarizes, tells, writes.
6. Evaluation- Evaluation is concerned with the ability to judge the value of material (statement, novel, poem, research report) for a given purpose. The judgements are to be based on definite criteria. These may be internal criteria (organization) or external criteria (relevance and purpose) and the student may determine the criteria or be given them. Learning outcomes in this area are highest in the cognitive hierarchy because they contain elements of all of the other categories, plus value judgements based on clearly defined criteria.
Illustrative General Instructional Objectives: Judges the consistency of written material. Judges the adequacy with which conclusions are supported by data. Judges the value of a work (art, music, writing) by using internal criteria. Judges the value of a work (art, music, writing) by use of external standards.
Illustrative Verbs for Stating Specific Learning Outcomes: Appraises, compares, concludes, contrasts, criticizes, describes, discriminates, explains, justifies, interprets, relates, summarizes, supports.
As an example, if we're considering a program for general ISO 9001:2015 awareness, then we’re really only looking at a basic level of knowledge (Level 1). In contrast, If we’re talking about training a practitioner that will have role in implementing and maintaining the management system, both comprehension and the application of requirements is necessary (Level 2 & 3). For key personnel, e.g., Lead Auditors and QMS Managers (Levels 4, 5, & 6), the longer the training, the better.
Benjamin S. Bloom, Bertram B. Mesia, and David R. Krathwohl (1964). Taxonomy of Educational Objectives (two vols: The Affective Domain & The Cognitive Domain). New York. David McKay
Ingredients for a Work Instruction
Pay close attention on this one….
Congratulations! – You have just made tomato soup.
It seems like I'm asked at least every other day for a work instruction template. The example above, while typically referred to above as a “recipe”, is a basic form of a work instruction. As for a “work instruction template”, there’s no hard-and-fast rules to follow on what a work instruction should or shouldn’t look like; there’s no ISO 9001 requirement; there’s no standardized format or template that everyone is supposed to follow.
Communication in written form requires a sender, a receiver, a message and an action / result. In the above example, the sender is the author; the receiver is the cook; the message is the recipe; and the result is tomato soup.
What content is required? Work instructions should be developed with the user in mind, and should convey information as necessary to achieve desired outcomes (in the above case, “making soup”). How simple or how complicated this instruction needs to be is a matter between the author and their intended audience (the user), with adequate consideration given to the complexity of the task at hand (or lack of).
What a work instruction looks like, the information contained within, is up to the individual preparing. Some work instructions include sections on “materials”, “equipment”, “personnel”, “related procedures”, etc. Some work instructions don’t. Some companies even have specific rules (i.e., a company style guide) and how these documents should be formatted.
In any case, the Written Instruction Template can be, and definitely should be, whatever works best for you, your organization and the outcomes your trying to accomplish.
It’s cold today and now I’m going to have my soup.
ISO 9001:2015 - Frequently Asked Questions
We're constantly getting questions about all things ISO 9001, and ISO 9001-related. We've decided to share some of the best questions we've been asked on our blog.
What is ISO 9001?
ISO 9001 is an international standard developed by the International Organization for Standardization for Quality Management Systems. "ISO" is not an acronym as would be expected; it is from the Ancient Greek isos, or "equal". The "9001" refers to the standard (Quality Management Systems), with "2015" referring to the year published.
Why do I need ISO 9001?
When talking about the "need" for ISO 9001, a true need would typically result from the requirements of a customer or other interested party, or as the result of a compliance obligation. However, many organizations do aspire to be ISO compliant, due to the potential benefits of improved performance, standardization, market recognition, etc.
What's the difference between being ISO 9001 compliant and ISO 9001 certified?
Compliance is a matter of meeting specified requirements. Certification refers to a written confirmation that specified requirements have been met, through a process of review by an external party. To be ISO 9001 certified therefore, it can be assumed that you've been audited by a third party and found compliant, with a written statement to that effect issued. With regards to ISO 9001, this written testimony is usually issued by an ISO Certifying Body or Registrar, which is accredited for such purpose.
What’s the difference between ISO 9001:2008 and ISO 9001:2015?
Any technical differences aside, ISO 9001:2015 is the replacement standard for ISO 9001:2008. It was issued in September of 2015, with a three year implementation window; as a result, ISO 9001:2008 will no longer be valid after September 2018.
ISO 9001 has a reputation for requiring a lot of documents. Do we still need to "document everything that we do"?
ISO 9001:2015 makes only a few references to documented information that must be "maintained" by an organization's Quality Management System; however, the new ISO 9001 standard does require that the organization ensure the effective operation and control of its processes. There is no longer a requirement for a quality manual, and there is no minimum number of procedures.
The minimum requirement for documented information that must be maintained includes: the Scope of the Quality Management System (4.4), Quality Policy (5.2) and Quality Objectives (6.2).
I plan to upgrade from ISO 9001:2008 to ISO 9001:2015. Can I keep my existing work instructions?
From our experience, aside from some reorganization, there's little changed between ISO 9001:2008 (7.0, Product Realization) and its replacement, ISO 9001:2015 (8.0, Operation). Assuming that day-to-day work operations are not impacted by the ISO 9001 upgrade, there shouldn't be any affect on existing work instructions.
Do I need to hire an ISO consultant to get ISO 9001 certified?
There's no ISO 9001 requirement for a consultant to be involved with your ISO 9001 certification efforts. You should consider a consultant if either your organization does not have sufficient resources or capacity to handle this task themselves, or alternatively, your organization lacks the technical skill and/or experience.
How long should ISO 9001 certification take?
How long it takes for a company to become compliant is an internal issue, which must take into account the number of employees, the complexity of the work performed, the stability and control of existing work processes, and the resources which will be allocated to support compliance efforts. Assuming no consultant involvement and limited experience, 1-2 years is not an unreasonable amount of time. Hiring a good consultant may be able to reduce this duration to a few months.
The amount of time to complete the actual process of certification would be in addition to any time spent on initial compliance efforts. Once the certification process is initiated with the Certifying Body, it is typically completed within 90-120 days.
How much should an ISO 9001 consultant cost?
This is the magic question asked by almost every organization. Pricing varies due to a range of factors, including company size, range of products, geographic location, etc., as well as the expertise, experience and reputation of the consultant themselves. We always recommend getting multiple quotes prior to making a decision.
Since the floods, we've had lots of critters come out of hiding...the latest is a baby coral snake!
Would this be an interested party, external factor, or nah?
Two of the most frequent inquiries we receive relating to the ISO 9001:2015 Standard are seeking help in understanding and determining "Context" and "Risk Based Thinking".
As for context, the easiest explanation is to consider it as an opportunity to present “about our company”. Who we are, what we do, how do we do it, and who do we do it for. For example, many companies may make chairs, but all chairs are not created equal (e.g., a chair may be for an office, a kitchen table, a bar, a plane, a patio, a pool, etc.). If your business was a painting on canvas, your context would be the background.
The best approach we’ve had so far is to replace the “old” ISO 9001:2008 manual with a “new” ISO 9001:2015 manual that addresses all of the above. Rather than just restating and paraphrasing the ISO 9001 standard, the QMS becomes the company’s explanation of its interested parties, products and processes, and how it manages quality. Once documented, it should be communicated internally, so everyone can understand and speak the same language.
As for risk based thinking, the only requirement of ISO 9001:2015 is that the organization can demonstrate that it is applying this concept. TC-176, the ISO technical committee responsible for this standard, intentionally didn’t prescribe any requirements, for fear of alienating the various users of the standard. Along with several other new requirements, this hesitation created more problems than it solved. Now the certification auditors are taking it upon themselves to mandate their own personal opinions…
The best approach we’ve had with this area is the use of a risk registry (list), detailing by each QMS process, what risks we consider to be important. Once identified, this registry is scored highest-to-lowest (based on whatever company-defined method is used), with the highest values being those which are considered to require immediate control. The rest can just be monitored for change. If you’re familiar with the term, think FMEA (Failure Modes Effects Analysis).
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